Dopamine vs. Norepinephrine for Hypotension in Neonates With Pulmonary Hypertension (DONE)

NCT07322133 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: 2339428GFDS25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot randomized clinical trial compares dopamine and norepinephrine as first-line vasoactive therapies in term and late preterm neonates with pulmonary hypertension associated with hypoxemic respiratory failure and systemic hypotension. Systemic hypotension is a common and clinically significant complication of persistent pulmonary hypertension of the newborn (PPHN) and frequently requires vasopressor support to maintain adequate systemic perfusion. Dopamine is commonly used in this setting; however, prior animal experimental and clinical data suggest it may increase pulmonary vascular resistance, potentially worsening right ventricular afterload and hypoxemia. Norepinephrine may preferentially increase systemic vascular resistance with less effect on the pulmonary circulation. This study evaluates short-term hemodynamic and oxygenation responses following initiation of dopamine or norepinephrine.

Conditions

Hypotension and Shock; Pulmonary Hypertension of the Newborn (PPHN); Hypoxemic Respiratory Failure

Keywords

Pulmonary Hypertension; Systemic Hypotension; Vasopressor

Outcome Measures

Primary Outcomes (3)

• SAP/PAP ratio

  Ratio of systemic arterial pressure to pulmonary arterial pressure (SAP/PAP)

  Within 30 hours of vasopressor initiation.

• LV Cardiac output

  Left Ventricular Cardiac Output calculated with echocardiography

  Within 30 hours of vasopressor initiation

• Oxygenation Indices

  FiO₂ (fraction of inspired oxygen), SpO₂ (peripheral oxygen saturation), PaO₂ (arterial oxygen partial pressure), OI (oxygenation index), OSI (oxygen saturation index)

  Within 30 hours of vasopressor initiation

Secondary Outcomes (3)

• Use of inhaled nitric oxide (iNO)

  Within 30 hours of vasopressor initiation

• Need for additional vasoactive agents

  Within 30 hours of vasopressor initiation

• Echocardiographic markers of heart function

  Within 30 hours of vasopressor initiation

Study Arms (2)

Dopamine Arm

ACTIVE COMPARATOR

Infants in this group will receive dopamine as their first-line vasopressor. Continuous intravenous dopamine infusion will be initiated at 5 mcg/kg/min and titrated to achieve gestational age appropriate mean arterial blood pressure targets (maximum 20 mcg/kg/min).

Drug: Dopamine administration

Norepinephrine Arm

ACTIVE COMPARATOR

Infants in this group will receive norepinephrine as their first-line vasopressor. Continuous intravenous norepinephrine infusion initiated at 0.02 mcg/kg/min and titrated to achieve gestational age appropriate mean arterial blood pressure targets (maximum 1 mcg/kg/min).

Drug: Norepinephrine

Interventions

Norepinephrine DRUG

Infants meeting the inclusion criteria who are randomized to norepinephrine arm will receive norepinephrine infusion starting at 0.02 mcg/kg/min, titrated to mean arterial pressure targets based on gestational age, max dose 1 mcg/kg/min.

Norepinephrine Arm

Dopamine administration DRUG

Infants meeting the inclusion criteria who are randomized to dopamine arm will receive dopamine infusion starting at 5 mcg/kg/min, titrated to mean arterial pressure targets based on gestational age, max dose 20 mcg/kg/min.

Dopamine Arm

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Postmenstrual age \> 34 6/7 weeks and Postnatal age ≤ 28 days
• On respiratory support (Invasive mechanical ventilation, NIPPV, CPAP, HFNC ≥ 2 LPM) and FiO2 ≥ 0.3
• Echocardiographic evidence of pulmonary hypertension
• Mean arterial pressure below the threshold for gestational age despite a 10-20 mL/kg fluid bolus
• Permissible Comorbidities: CDH, trisomy 21, HIE on hypothermia, PDA, PFO/ASD, VSD \< 2 mm

You may not qualify if:

• Gestational age \< 32 weeks
• Severe hypoxic respiratory failure (OI \> 35 or SpO2 \< 75% on 100% FiO2 for \> 60 minutes)
• Lethal anomalies (e.g., trisomy 13 or 18)
• Complex congenital heart disease beyond specified criteria

Sponsors & Collaborators

• Children's Miracle Network: collaborator
• University of California, Davis: lead

Study Sites (1)

UC Davis Children's Hospital

Sacramento, California, 95817, United States

RECRUITING

Related Publications (14)

• Jain A, El-Khuffash AF, van Herpen CH, Resende MHF, Giesinger RE, Weisz D, Mertens L, Jankov RP, McNamara PJ. Cardiac Function and Ventricular Interactions in Persistent Pulmonary Hypertension of the Newborn. Pediatr Crit Care Med. 2021 Feb 1;22(2):e145-e157. doi: 10.1097/PCC.0000000000002579.

  PMID: 33044416 BACKGROUND

• Lesneski AL, Vali P, Hardie ME, Lakshminrusimha S, Sankaran D. Randomized Trial of Oxygen Saturation Targets during and after Resuscitation and Reversal of Ductal Flow in an Ovine Model of Meconium Aspiration and Pulmonary Hypertension. Children (Basel). 2021 Jul 14;8(7):594. doi: 10.3390/children8070594.

  PMID: 34356574 BACKGROUND

• Siefkes HM, Lakshminrusimha S. Management of systemic hypotension in term infants with persistent pulmonary hypertension of the newborn: an illustrated review. Arch Dis Child Fetal Neonatal Ed. 2021 Jul;106(4):446-455. doi: 10.1136/archdischild-2020-319705. Epub 2021 Jan 21.

  PMID: 33478959 BACKGROUND

• Lakshminrusimha S. The pulmonary circulation in neonatal respiratory failure. Clin Perinatol. 2012 Sep;39(3):655-83. doi: 10.1016/j.clp.2012.06.006.

  PMID: 22954275 BACKGROUND

• Tourneux P, Rakza T, Bouissou A, Krim G, Storme L. Pulmonary circulatory effects of norepinephrine in newborn infants with persistent pulmonary hypertension. J Pediatr. 2008 Sep;153(3):345-9. doi: 10.1016/j.jpeds.2008.03.007. Epub 2008 May 12.

  PMID: 18534241 BACKGROUND

• Steinhorn RH. Neonatal pulmonary hypertension. Pediatr Crit Care Med. 2010 Mar;11(2 Suppl):S79-84. doi: 10.1097/PCC.0b013e3181c76cdc.

  PMID: 20216169 BACKGROUND

• Sankaran D, Lakshminrusimha S. Pulmonary hypertension in the newborn- etiology and pathogenesis. Semin Fetal Neonatal Med. 2022 Aug;27(4):101381. doi: 10.1016/j.siny.2022.101381. Epub 2022 Aug 7.

  PMID: 35963740 BACKGROUND

• McNamara PJ, Giesinger RE, Lakshminrusimha S. Dopamine and Neonatal Pulmonary Hypertension-Pressing Need for a Better Pressor? J Pediatr. 2022 Jul;246:242-250. doi: 10.1016/j.jpeds.2022.03.022. Epub 2022 Mar 18. No abstract available.

  PMID: 35314154 BACKGROUND

• Liet JM, Boscher C, Gras-Leguen C, Gournay V, Debillon T, Roze JC. Dopamine effects on pulmonary artery pressure in hypotensive preterm infants with patent ductus arteriosus. J Pediatr. 2002 Mar;140(3):373-5. doi: 10.1067/mpd.2002.123100.

  PMID: 11953739 BACKGROUND

• Cheung PY, Barrington KJ. The effects of dopamine and epinephrine on hemodynamics and oxygen metabolism in hypoxic anesthetized piglets. Crit Care. 2001;5(3):158-66. doi: 10.1186/cc1016. Epub 2001 Apr 26.

  PMID: 11353933 BACKGROUND

• Budniok T, ElSayed Y, Louis D. Effect of Vasopressin on Systemic and Pulmonary Hemodynamics in Neonates. Am J Perinatol. 2021 Oct;38(12):1330-1334. doi: 10.1055/s-0040-1712999. Epub 2020 Jun 2.

  PMID: 32485754 BACKGROUND

• Shah S, Dhalait S, Fursule A, Khandare J, Kaul A. Use of Vasopressin as Rescue Therapy in Refractory Hypoxia and Refractory Systemic Hypotension in Term Neonates with Severe Persistent Pulmonary Hypertension-A Prospective Observational Study. Am J Perinatol. 2024 May;41(S 01):e886-e892. doi: 10.1055/a-1969-1119. Epub 2022 Oct 27.

  PMID: 36302521 BACKGROUND

• McNamara PJ, Jain A, El-Khuffash A, Giesinger R, Weisz D, Freud L, Levy PT, Bhombal S, de Boode W, Leone T, Richards B, Singh Y, Acevedo JM, Simpson J, Noori S, Lai WW. Guidelines and Recommendations for Targeted Neonatal Echocardiography and Cardiac Point-of-Care Ultrasound in the Neonatal Intensive Care Unit: An Update from the American Society of Echocardiography. J Am Soc Echocardiogr. 2024 Feb;37(2):171-215. doi: 10.1016/j.echo.2023.11.016.

  PMID: 38309835 BACKGROUND

• de Boode WP, Singh Y, Gupta S, Austin T, Bohlin K, Dempsey E, Groves A, Eriksen BH, van Laere D, Molnar Z, Nestaas E, Rogerson S, Schubert U, Tissot C, van der Lee R, van Overmeire B, El-Khuffash A. Recommendations for neonatologist performed echocardiography in Europe: Consensus Statement endorsed by European Society for Paediatric Research (ESPR) and European Society for Neonatology (ESN). Pediatr Res. 2016 Oct;80(4):465-71. doi: 10.1038/pr.2016.126. Epub 2016 Jun 8. No abstract available.

  PMID: 27384404 BACKGROUND

MeSH Terms

Conditions

Hypotension; Shock; Respiratory Insufficiency; Hypertension, Pulmonary

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Hypertension

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Deepika Sankaran, MD

  UC Davis Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Solomon P Tatagiri, MBBS

CONTACT

916-734-8672; solomontp@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 7, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)